Kornimate/medical-research-clean huggingface dataset:
a study of adavosertib (mk-1775) in combination with topotecan/cisplatin in participants with cervical cancer (mk-1775-008)

Conditions: Cervical Cancer

Summary: this study will be conducted in two parts. part 1 will determine whether administration of adavosertib in combination with topotecan and cisplatin is generally well-tolerated and causes clinical objective responses in patients with cervical cancer. part 1 will also define the recommended phase 2 dose and maximum tolerated dose (mtd) of the combination of adavosertib with topotecan and cisplatin. part 2 of the study will evaluate whether treatment with adavosertib in combination with topotecan and cisplatin causes an improvement in progression-free survival (pfs) compared to treatment with topotecan and cisplatin alone and will further evaluate the tolerability of the combination treatment. the primary hypothesis is the combination of adavosertib, topotecan and cisplatin causes objective radiological responses (assessed per response evaluation criteria in solid tumors \[recist\] 1.1 criteria) in ≥30% of participants. due to the early termination of the study by the sponsor, no participants were enrolled in part 2 of the study.


Eligibility criteria:
inclusion criteria: * has advanced, metastatic, and recurrent squamous cell, adenosquamous, or adeno-carcinoma of the uterine cervix (stage ii - ivb) * has received cisplatin in combination with radiation as initial or adjuvant treatment for their cervical cancer * has not received any other treatment for their cancer following the cisplatin-based chemo-radiation or targeted therapy except non-cytotoxic targeted therapy * recurrence must be at least 6 months post cisplatin-based chemotherapy * has measurable disease * performance status on the eastern cooperative oncology group (ecog) performance scale is less than or equal to 1 * has a negative pregnancy test within 72 hours of the first dose of study medication exclusion criteria: * has had chemotherapy, radiotherapy, or biological therapy within 6 months of entering the study * has a history of vascular thrombotic events or vascular reconstruction * has active central nervous system (cns) metastases and/or carcinomatous meningitis * has a primary cns tumor * requires the use of medications or products that are metabolized by, or inhibit or induce cyp3a4 (cytochrome p450 3a4) * is expecting to reproduce within the duration of the study or is pregnant or breastfeeding * is known to be human immunodeficiency virus (hiv)-positive * has known active hepatitis b or c * has a known history of interstitial lung disease or pulmonary fibrosis * has symptomatic ascites or pleural effusion * has a clinical history suggestive of li-fraumeni syndrome
safety study of hsv2 dna vaccine to treat patients with recurrent genital herpes caused by hsv-2

Conditions: HSV-2

Summary: the purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given and any effects it may have on subjects' wellbeing. the study will also test the ability of vaccine to cause particular immune responses in the body and evaluate the effect it has on herpes outbreaks

herpes simplex virus type 2 (hsv-2) infection is a serious public health problem, with up to 20% of the us population infected. following primary infection, hsv-2 establishes a latent infection that can lead to recurrent disease when the virus reactivates. genital lesions are often experienced with viral recurrence and these can be uncomfortable and painful, resulting in significant anxiety and social distress. there are no commercial vaccines available for therapy of hsv-2 infection.the aim of a therapeutic vaccine would be to enhance such natural responses by boosting the appropriate cellular immune response to hsv-2 in those latently infected individuals who experience frequent and unwanted reactivations. the purpose of this study is to evaluate the safety and tolerability profile of the ppjv7630 hsv-2 dna vaccine as administered by particle mediated epidermal delivery (pmed )

Eligibility criteria:
otherwise healthy subjects with recurrent genital herpes due to hsv-2 infection

Keywords: dna vaccine immunotherapy herpes simplex virus type 2 (hsv2) particle mediated epidermal delivery
glucomannan effects on children with non-alcoholic fatty liver disease

Conditions: Metabolic Syndrome; Non Alcoholic Fatty Liver Disease; Insulin Resistance

Summary: non-alcoholic fatty liver disease (nafld) has reached epidemic proportions and is rapidly becoming the one of most common causes of chronic liver disease in children. the pathogenesis of nafld is generally considered the result of a series of liver injuries, commonly referred as "multi-hit" hypothesis. insulin resistance and increased serum levels of free fatty acids (ffas) are considered the main primary hits that lead to the excessive lipid accumulation in hepatocytes resulting in steatosis. has been reported that a diet rich in high-viscosity fiber improves glycemic control and lipid profile, suggesting a therapeutic potential role in the treatment of nafld. aim of this study is to evaluate the efficacy and tolerability of glucomannan in children affected by non alcoholic fatty liver disease.


Eligibility criteria:
inclusion criteria: * informed consent by parents or legal tutor * alt levels \<10 uln * hyperechogenicity at liver ultrasound examination suggestive of fatty liver * inr \< 1,3 * albumin \> 3 g/dl * total bilirubin \< 2,5 mg/dl * no previous gastrointestinal bleeding * no previous portosystemic encephalopathy * normal renal function * no hiv-hcv-hdv infection * normal cell blood count exclusion criteria: * every clinical or psychiatric disease interfering with experimentation according to investigator's evaluation * finding of active liver disease due to other causes * corticosteroids, immunosuppressive drugs or chemotherapy in the 2 months before of the study * alcohol consumption * use of drugs known to induce steatosis or to affect body weight and carbohydrate metabolism * finding of actual or previous level of alpha-fetoprotein \> 50 ng/ml * hepatocellular carcinoma * diabetes mellitus type i

Keywords: nafld insulin resistance children
oxytocin and social cognition in frontotemporal dementia

Conditions: Frontotemporal Dementia; Pick's Disease

Summary: investigations into the components of cognition damaged in frontotemporal dementia (ftd) demonstrate that patients with ftd show deficits in facial and verbal expression recognition, lack insight into what others think or might do (theory of mind skills), and in decision making tasks requiring processing of positive versus negative feedback. these cognitive functions are thought to be critical for appropriate social behavioural regulation (blair, 2003). recent studies in animal models and humans suggest that the neuropeptide oxytocin is an important mediator of social behavior and that oxytocin may facilitate emotion recognition, theory of mind processing, and prosocial behaviors (donaldson and young, 2008). together, these findings suggest that upregulation of oxytocin dependent mechanisms of social and emotional cognition may be a valuable treatment approach in patients with ftd. the aim of this study is to determine how administration of intranasal oxytocin to patients with frontotemporal dementia affects behavior and processing of specific types of social and emotional information.the investigators' hypothesis is that oxytocin administration will improve emotional and social cognitive deficits in patients with ftd, resulting in improved decision making and behaviour.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of probable frontotemporal dementia or pick's disease * caregiver available to participate in all study visits exclusion criteria: * severe language or memory deficits that preclude completion of the cognitive tasks * females who are pregnant or breastfeeding (a pregnancy test will be done on females who have not completed menopause) * uncontrolled hypertension * bradycardia (rate \ 100 bpm) * current use of prostaglandins * use of any investigational or experimental drug or device within the last 60 days prior to screening or within 5 half-lives of the experimental drug , whichever is longer

Keywords: social cognition oxytocin
treatment of radiation retinopathy trial

Conditions: Uveal Melanoma

Summary: the purpose of this study is to demonstrate a statistically significant improvement of visual acuity after treatment using either lucentis® or triamcinolone® compared to no treatment, in patients with radiation retinopathy.

approximately 30-40% of patients develop a deterioration of visual acuity within 5 years after treatment of uveal melanoma using radiation therapy and ttt due to radiation retinopathy (shields 2002, bartlema 2003). by administration of either lucentis® or triamcinolone® we hope to treat complications of radiation therapy, by demonstrating a statistically significant improvement in visual acuity and a reduced amount of macular edema and vascular leakage. additionally, we hope to obtain a better understanding of the pathophysiologic processes involved, by demonstrating a possible relation between high levels of angiogenic factors (vegf) in the anterior chamber fluid, and radiation retinopathy. in conclusion, we hope to provide evidence for a new therapy in patients with retinopathy, due to radiation in uveal melanoma. there is no scientifically proven treatment available at this time.

Eligibility criteria:
inclusion criteria: * the eye was previously irradiated for treatment of a uveal melanoma; * decrease of visual acuity after irradiation therapy by more than 10 letters (etdrs) and is now 20/40 or less; * vision decrease is considered to be due to central radiation retinopathy with significant macular edema or optic disc edema; * age 18 years or older; * the patient is fully competent; * written informed consent to participate in the trial is given. * patient is not pregnant (or not fertile) and is willing to use contraceptives for the duration of the trial (one year) * patient is willing and able to return for follow-up. exclusion criteria: * vision decrease is considered to be due to ischemic radiation retinopathy without macular edema or optic disc edema; * other, approved therapy indicated for treatment of condition; * presence of metastasis; * evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial; * pre-existing retinopathy due to other disorders;

Keywords: radiation retinopathy maculopathy choroidopathy uveal melanoma lucentis ranibizumab kenalog triamcinolone acetonide radiation retinopathy after irradiation of uveal melanoma radiation maculopathy after irradiation of uveal melanoma radiation choroidopathy after irradiation of uveal melanoma
221ad301 phase 3 study of aducanumab (biib037) in early alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the clinical dementia rating-sum of boxes (cdr-sb) score as compared with placebo in participants with early ad. secondary objectives are to assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by mini-mental state examination (mmse), ad assessment scale-cognitive subscale (13 items) \[adas-cog 13\], and ad cooperative study-activities of daily living inventory (mild cognitive impairment version) \[adcs-adl-mci\].


Eligibility criteria:
key inclusion criteria: * must meet all of the following clinical criteria for mci due to ad or mild ad and must have: * a clinical dementia rating (cdr)-global score of 0.5. * objective evidence of cognitive impairment at screening * an mmse score between 24 and 30 (inclusive) * must have a positive amyloid positron emission tomography (pet) scan * must consent to apolipoprotein e (apoe) genotyping * if using drugs to treat symptoms related to ad, doses must be stable for at least 8 weeks prior to screening visit 1 * must have a reliable informant or caregiver key exclusion criteria: * any medical or neurological condition (other than alzheimer's disease) that might be a contributing cause of the subject's cognitive impairment * have had a stroke or transient ischemic attack (tia) or unexplained loss of consciousness in the past 1 year * clinically significant unstable psychiatric illness in past 6 months * history of unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities within 1 year prior to screening * indication of impaired renal or liver function * have human immunodeficiency virus (hiv) infection * have a significant systematic illness or infection in past 30 days * relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities * any contraindications to brain magnetic resonance imaging (mri) or pet scans * alcohol or substance abuse in past 1 year * taking blood thinners (except for aspirin at a prophylactic dose or less) note: other protocol defined inclusion/exclusion criteria may apply

Keywords: biib037 aducanumab
fecal microbiota transplantation (fmt): prim-dj2727

Conditions: Recurrent Clostridium Difficile Infection; Multidrug-resistant Klebsiella Pneumoniae Urinary Tract Infection

Summary: the fecal microbiota transplantation (fmt) product prim-dj2727 is prepared from human stool from a healthy, screened donor. requestors will contact the study team about the product (prim-dj2727) by email, visit, or phone call. a screening list for donors will be provided to make sure that the list fits the requestor's requirements. a basic fee will be requested to recover the cost of making the product. after an agreement is made, a contract will be signed between the 2 parties. a week before the treatment, requestors will contact the study team for possible fmt product delivery. delivery method will be confirmed for delivery by personnel (within 10 minutes driving distance) or by using fedex services. each delivered product will have an approved delivery form signed and dated by both the person who prepared the delivery and the person who received the package.


Eligibility criteria:
inclusion criteria: - exclusion criteria: -
a study of su11248 in patients with metastatic breast cancer who have failed selected other therapies.

Conditions: Breast Neoplasms

Summary: assessment of safety and efficacy of su11248 in patients with metastatic breast cancer who have failed selected other therapies.


Eligibility criteria:
inclusion criteria: * anthracycline and taxane-refractory or intolerant metastatic breast cancer * female exclusion criteria: * prior treatment with 3 or greater regimens of chemotherapy in the advanced/metastatic disease setting beyond those containing anthracyclines/taxanes.
a 12-week safety and pharmacodynamic study of at1001 (migalastat hydrochloride) in participants with fabry disease

Conditions: Fabry Disease

Summary: study to evaluate the safety, tolerability, and pharmacodynamics of migalastat hydrochloride (hcl) (migalastat) and how migalastat works in participants with fabry disease.

this was a phase 2, open-label study in male participants with fabry disease. the study consisted of a 4-week screening period during which participants' genotype was assessed for α-galactosidase a (α-gal a) activity in response to migalastat via an in vitro assay. participants were required to have α-gal a activity responsive to migalastat. the study consisted of a 12-week treatment period, followed by an optional 36-week extension period. participants received migalastat 150 milligrams (mg) once every other day (qod) for 12 weeks during the treatment period. participants could then opt to participate in the extension period.

Eligibility criteria:
inclusion criteria: * males between 18 and 65 years of age (inclusive) * hemizygous for fabry disease * had a confirmed diagnosis of fabry disease with a documented missense gene mutation (individual or familial) * had enhanceable enzyme activity based on in vitro tests * had documented evidence of cardiac and/or renal dysfunction (for example, abnormal electrocardiogram (ecg), left ventricular hypertrophy, renal insufficiency) and/or cerebral tissue dysfunction documented by evidence of stroke and/or peripheral nervous tissue dysfunction (for example, intolerance to heat/cold, decrease of perspiration) * must have been previously untreated by enzyme replacement therapy (ert) or substrate depletion for fabry disease or were able to stop ert for at least 18 weeks or up to three months, and be willing to undergo two kidney and three skin biopsies * agreed to be sexually abstinent or use a condom with spermicide when engaging in sexual activity during the course of the study and for a period of 30 days following their completion of the study * were willing and able to sign an informed consent form exclusion criteria: * history of significant disease other than fabry disease * history of organ transplant * serum creatinine \>2 mg per deciliter on day -2 * screening 12-lead ecg demonstrating corrected qt interval \>450 milliseconds prior to dosing * pacemaker or other contraindication for magnetic resonance imaging (mri) scanning * took any of the following prohibited medications: fabrazyme® (agalsidase beta), replagal™ (agalsidase alfa), glyset® (miglitol), zavesca® (miglustat), or any experimental therapy for any indication * participated in a previous clinical trial in the last 30 days * any other condition, which, in the opinion of the investigator, would jeopardize the safety of the participant or impact the validity of the study results

Keywords: amicus therapeutics at1001 galafold migalastat substrate
trial to assess the safety and tolerability of lucinactant for inhalation in premature neonates

Conditions: Respiratory Distress Syndrome

Summary: the primary objective of this study is to evaluate the safety and tolerability of aerosolized surfactant, specifically lucinactant for inhalation, administered in escalating inhaled doses to preterm neonates 29 to 34 weeks gestational age who are receiving nasal continuous positive airway pressure (ncpap) for respiratory distress syndrome (rds), compared to neonates receiving ncpap alone.


Eligibility criteria:
inclusion criteria: * informed consent from a legally authorized representative * gestational age 29 to 34 completed weeks (34 weeks 6 days) post menstrual age (pma) * successful implementation of controlled ncpap within 90 minutes after birth * spontaneous breathing * chest radiograph consistent with rds * need for moderate levels of supplemental oxygen and ncpap to maintain oxygen saturation of 88% to 95% for at least 30 minutes within the first 21 hours after birth exclusion criteria: * heart rate that cannot be stabilized above 100 beats/minute within 5 minutes of birth * recurrent episodes of apnea occurring after the initial newborn resuscitation period (ie, 10 minutes after birth) requiring intermittent positive pressure breaths using inflating pressures above the set cpap pressure administered manually or mechanically through any patient interface * a 5 minute apgar score \< 5 * major congenital malformation(s) and cranial/facial abnormalities that preclude ncpap, diagnosed antenatally or immediately after birth * other diseases or conditions potentially interfering with cardiopulmonary function (eg, hydrops fetalis or congenital infection such as torch) * known or suspected chromosomal abnormality or syndrome * prolong rupture of membranes (prom) \> 2 weeks * evidence of hemodynamic instability requiring vasopressors or steroids for hemodynamic support and/or presumed clinical sepsis * need for endotracheal intubation and mechanical ventilation * has been administered: another investigational agent or exposure to an investigational medical device, any other surfactant agent, steroid treatment after birth
perceptual retraining to reduce suicide risk

Conditions: Perceptual Olfactory Bias

Summary: the study will use a prospective design consisting of three phases. the phases are: 1. the development of the perceptual retraining treatment (prt), 2. the evaluation of the treatment's feasibility and acceptability, and 3. an assessment of its efficacy. during the third phase, a pilot study will be conducted in which participants will be randomly assigned to either prt or a waitlist control group in order to assess efficacy. diagnostic information and eligibility criteria will be assessed using the structured clinical interview for diagnostic and statistical manual (dsm) 4th ed. (scid) and the clinician administered ptsd scale for dsm-5 (caps-5).

this study will use clinical interviews, self-report measures, and behavioral assessments to evaluate the efficacy of the prt protocol. the study will recruit approximately 30 veterans. the primary inclusionary criterion will be that participants must show some evidence of olfactory perceptual bias toward military-relevant stimuli (e.g., burning rubber, decay, fuel). investigators are not requiring current suicidal ideation as an entry criterion because investigators believe that a fair percentage of veterans will have some suicidal ideation/intent but making this an entry requirement will limit the investigators ability to recruit given the tight timeline for the study. the study will consist of the development and evaluation of a novel intervention. the essential feature of this intervention is the use of a gradient of triggering smells (e.g., burning rubber, decay, fuel, etc.), to which participants will be systematically exposed in an effort to facilitate habituation to these odors. the prt protocol will be administered over two 1-hour sessions. participants will return 1 month after their final prt protocol session to complete a battery of follow-up measures, as well as the caps-5. the primary outcome measures of interest are: olfactory perceptual bias (as measured by the olfactory bias assessment), suicidal ideation and behaviors (as measured by the beck suicide scale and depressive symptom inventory- suicidality subscale), and symptoms related to suicide, such as anxiety and trauma (as measured by the beck anxiety inventory and ptsd checklist for dsm-5, respectively).

Eligibility criteria:
inclusion criteria: * evidence of olfactory perceptual bias toward military-relevant stimuli (e.g., burning rubber, decay, fuel). * military combat exposure in operation iraqi freedom, enduring freedom, or new dawn. * age 18-60. exclusion criteria: * significant medical illness that compromises olfactory perception or tolerance (e.g., significant olfactory disease or dysfunction, cardiovascular disease, respiratory disorders, renal disease, epilepsy, stroke, and uncontrolled hypertension or migraines). * evidence of imminent suicidal intent * evidence of current or past psychotic-spectrum disorders, or uncontrolled bipolar disorder. * english speakers.